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CTRI Number  CTRI/2021/08/036001 [Registered on: 27/08/2021] Trial Registered Prospectively
Last Modified On: 23/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the accuracy of two clip placing instruments. 
Scientific Title of Study   Comparing the accuracy of bracket positioning with ABC gauge and MBT gauge-A split mouth randomized clinical trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAbhiram Cherukuri 
Designation  Postgraduate student Orthodontics 
Affiliation  RGUHS 
Address  Room number 7 Department of orthodontics and dentofacial orthopedics KLE SOCIETYS INSTITUTE OF DENTAL SCIENCES Yeshwanthpur SuburbTumkur Road Bengaluru
Room number 7 Department of orthodontics and dentofacial orthopedicsKLE Societys institute of dental sciences BengaluruYeshwanthpur Suburb Tumkur Road Bengaluru
Bangalore
KARNATAKA
560097
India 
Phone  9741836504  
Fax    
Email  drabortho@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSumitra 
Designation  Head of the department  
Affiliation  RGUHS 
Address  Room number 7 Department of orthodontics and dentofacial orthopedicsKLE SOCIETYS INSTITUTE OF DENTAL SCIENCES Yeshwanthpur SuburbTumkur Road
Room number 7 Department of orthodontics and dentofacial orthopedicsKLE SOCIETYS INSTITUTE OF DENTAL SCIENCES Yeshwanthpur Suburb Tumkur Road
Bangalore
KARNATAKA
560097
India 
Phone  9448388716  
Fax    
Email  sumayjr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhiram Cherukuri 
Designation  Postgraduate student orthodontics 
Affiliation  RGUHS 
Address  Room number 7 Department of orthodontics and dentofacial orthopedics KLE SOCIETYS INSTITUTE OF DENTAL SCIENCES Yeshwanthpur Suburb Tumkur Road
Room number 7 Department of orthodontics and dentofacial orthopedics KLE SOCIETYS INSTITUTE OF DENTAL SCIENCES Yeshwanthpur Suburb Tumkur Road
Bangalore Rural
KARNATAKA
560097
India 
Phone  9741836504  
Fax    
Email  drabortho@gmail.com  
 
Source of Monetary or Material Support  
KLE society institute of dental sciences Bangalore 
 
Primary Sponsor  
Name  Dr Abhiram Cherukuri 
Address  KLE society institute of dental sciences Bengaluru 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhiram Cherukuri  Department of orthodontics and dentofacial orthopedics  Room number 7 Department of orthodontics and dentofacial orthopedics KLE SOCIETYS INSTITUTE OF DENTAL SCIENCES Yeshwanthpur Suburb Tumkur Road
Bangalore
KARNATAKA 		 9741836504

drabortho@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ABC bracket positioning gauge   A new bracket positioning gauge will be used to place brackets on teeth of patients to compare its accuracy with the MBT bracket positioning gauge group with the duration of study being 6 months . 
Comparator Agent  MBT Bracket positioning gauge  MBT bracket positioning gauge will be used to position the brackets on patients teeth to check the accuracy of the gauge and compared with ABC gauge with the duration of study being 6 months . 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Individuals with the presence of fully erupted permanent teeth till 1st molar having normal tooth size for proper bracket positioning will be selected for the study. 
 
ExclusionCriteria 
Details  Cases where the initial malocclusion prevented ideal bracket placement, or where observation of the mesiodistal position of the brackets was obscured by crowding 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the accuracy of bracket positioning along the long axis of the tooth with the ABC gauge and MBT gauge.   6months  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate and compare accuracy of bracket positioning in mesiodistal and vertical aspect with ABC gauge and MBT gauge.   6 months  
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abhiram.206@gmail.com].

  6. For how long will this data be available start date provided 15-07-2021 and end date provided 15-09-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The main aim of modern orthodontics is to create the finest occlusal relationship within the framework of acceptable facial aesthetics and stability which requires accurate positioning the crown of each individual tooth for optimum function and appearance. With the advent of pre-adjusted appliance, great emphasis is being laid on accurate bracket positioning for the efficient application of biomechanics and for utilizing the full potential of this appliance. Proper use of bracket positioning gauge adds to the accuracy of the bracket positioning ,hence various attempts have been made in improving efficiency in bracket positioning which led to the emergence of various designs of bracket positioners. In this study we aimed to minimize the errors in orienting the brackets along the long axis of the tooth, to minimize the errors in vertical, mesiodistal aspects and also to reduce the number of instruments used for accurate bracket positioning by fabricating the ABC gauge.
 
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